# K200021: Applied Medical Anoscope

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Jan 6, 2021 after 366 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993738 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070913: Self-Light Disposable Anoscope, Sapimed S.P.A. (2007) Summary page 4.

## Indications for use
The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

Source page: https://510kreport.com/device/K200021
Methodology: https://510kreport.com/methodology